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INVOTEC INTERNATIONAL, INC.

USA · Jacksonville

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

34listed device types

Class I 21Class II 11Class III 0unclassified 2

plus 34 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 1Class II 5

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

7 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States34 registration records, 16 510(k), 0 PMA

Brazil6 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: INVOTEC INTERNATIONAL, INC. · INVOTEC INTERNATIONAL INC · INVOTEC INTERNATIONAL INC. · Invotec International, Inc.

FDA 510(k) clearances by year

61990

31991

11993

31997

12003

12008

12013

FDA listed device types

showing 8 of 34

Punch, Nasal 1Knife, Nasal 1Dressing, Wound, Occlusive 1Tube, Ear Suction 1Splint, Intranasal Septal 1Splint, Nasal 1Forceps, Ent 1Pack, Hot Or Cold, Reusable 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K122040	INVOTEC LARYNGEAL ELECTRODE	2013-10-31
US	K080740	CLEARVIEW ENDOSCOPE COVER	2008-12-31
US	K030492	TITANIUM OSSICULAR REPLACMENT SYSTEM	2003-03-03
BR	80175170010	Eletrodo de Agulha Invotec	Class II
BR	80175170008	ELETRODO DE SUPERFÍCIE 29-80500	Class II
BR	80175170007	Brocas Cortantes em Aço Carbide	Class II
SA	ME0000006950SFDAA00014	External Nasal Splint	—
SA	ME0000006950SFDAA00015	Bright Star ll	—

INVOTEC INTERNATIONAL, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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